Intravesical Bacteriophage Treatment for Urinary Tract InfectionsPhase 2/3NCT03140085
Bacteriophages for Treating Urinary Tract Infections in Patients Undergoing Transurethral Resection of the Prostate
A Phase 2/3 study testing PYO Phage, Antibiotics and Sterile bacteriology media in people with Intravesical Bacteriophage Treatment for Urinary Tract Infections, run by Balgrist University Hospital at 1 site in Georgia.
Trial summary
Urinary tract infections are among the most prevalent microbial diseases and their financial burden on society is substantial. The use of bacteriophages against bacterial pathogens has gained over the last years a renewed interest, because of the continuing increase in antibiotic resistance worldwide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intravesical Bacteriophage Treatment for Urinary Tract Infections
- What is being tested?
- PYO Phage, Antibiotics and Sterile bacteriology media
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteGeorgia
- Study dates
- 2 Jun 2017to 14 Dec 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with urinary tract infections who are scheduled for transurethral resection of the prostate with urine culture (taken by mid-stream urine; or from the existing transurethral or suprapubic catheter) ≥104 colony forming units /mL of predefined uropathogens, including Enterococcus spp., Escherichia coli, Proteus mirabilis, Pseudomonas aeruginosa, Staphylococcus spp., and Streptococcus spp. and lower urinary tract symptoms such as urgency, frequency, dysuria, increased number of incontinence episodes
- Written informed consent.
Who cannot join
- Fever >38°C
- CRP >100mg/L
- Acute prostatitis
- Concomitant fungal urinary tract infection
- Current antibiotic treatment or antibiotic treatment within the last 7 days (exceptions: subjects with an active catheter associated urinary tract infection who have received prior antibiotics may be enrolled provided a minimum of 48 hours has elapsed between the last dose of the prior antibiotic and the time of obtaining the baseline urine specimen. Subjects receiving current antibiotic prophylaxis for catheter associated urinary tract infection who present signs and symptoms consistent with an active new catheter associated infection may be enrolled provided all other eligibility criteria are met including obtaining a pre-treatment qualifying baseline urine culture)
- Any rapidly progressing disease or immediately life-threatening illness including but not limited to: acute hepatic failure, respiratory failure, and septic shock
- No informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bacteriophages for Treating Urinary Tract Infections in Patients Undergoing Transurethral Resection of the Prostate: A Randomized, Placebo-controlled, Double-blind Clinical Trial
Urinary tract infections are among the most prevalent microbial diseases and their financial burden on society is substantial. The use of bacteriophages against bacterial pathogens has gained over the last years a renewed interest, because of the continuing increase in antibiotic resistance worldwide. Thus, the aim of this study is to investigate the efficacy of intravesical bacteriophage treatment to normalize urine culture compared to intravesical placebo or standard antibiotic treatment in a randomized controlled trial following a pilot phase.
- Being tested
- PYO Phage, Antibiotics, Sterile bacteriology media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PYO PhageBiological
Intravescial instillation
AntibioticsDrug
Oral application
Sterile bacteriology mediaOther
Sterile bacteriology media, with identical color as bacteriophage preparation
| Study group | Role | What they receive |
|---|---|---|
| Anbiotica | Active comparator | Not described Receives: Drug: Antibiotics |
| Bacteriophages | Active comparator | Not described Receives: Biological: PYO Phage |
| Placebo | Placebo comparator | Not described Receives: Other: Sterile bacteriology media |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normalisation of urine culture
Success of intravesical treatment, defined as normalization of urine culture (no evidence of bacteria, i.e. <104 colony forming units/mL) after 7 days of bacteriophage, placebo, or antibiotic treatment
Measured: 7 days after treatment
Secondary outcomes (4)
Urine culture
Measured: Baseline and 7 days after treatment
Bladder diary
Assessment of number of voids, number of leakages, post void residual
Measured: Baseline and 7 days after treatment
Pain diary
Visual analog scale (0 (no pain) to 10 (strongest possible pain))
Measured: Baseline and 7 days after treatment
IPSS questionnaire
Measured: Baseline and 7 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start2 Jun 2017
- Primary completion14 Dec 2018
- Study completion14 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intravesical Bacteriophage Treatment for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Kessler, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140085
- Sponsor's protocol ID
- 02/283
- Status last verified
- Mar 2019
- First submitted
- 27 Apr 2017
- Last updated
- 21 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Leitner L, Ujmajuridze A, Chanishvili N, Goderdzishvili M, Chkonia I, Rigvava S, Chkhotua A, Changashvili G, McCallin S, Schneider MP, Liechti MD, Mehnert U, Bachmann LM, Sybesma W, Kessler TM. Intravesical bacteriophages for treating urinary tract infections in patients undergoing transurethral resection of the prostate: a randomised, placebo-controlled, double-blind clinical trial. Lancet Infect Dis. 2021 Mar;21(3):427-436. doi: 10.1016/S1473-3099(20)30330-3. Epub 2020 Sep 16.
PubMed 32949500Leitner L, Sybesma W, Chanishvili N, Goderdzishvili M, Chkhotua A, Ujmajuridze A, Schneider MP, Sartori A, Mehnert U, Bachmann LM, Kessler TM. Bacteriophages for treating urinary tract infections in patients undergoing transurethral resection of the prostate: a randomized, placebo-controlled, double-blind clinical trial. BMC Urol. 2017 Sep 26;17(1):90. doi: 10.1186/s12894-017-0283-6.
PubMed 28950849
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacteriophages for Treating Urinary Tract Infections in Patients Undergoing Transurethral Resection of the Prostate: A Randomized, Placebo-controlled, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT03140085
- Acronym / sponsor ID
- 02/283
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 14 Dec 2018 (actual)
- First posted
- 4 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Urinary tract infections are among the most prevalent microbial diseases and their financial burden on society is substantial. The use of bacteriophages against bacterial pathogens has gained over the last years a renewed interest, because of the continuing increase in antibiotic resistance worldwide. Thus, the aim of this study is to investigate the efficacy of intravesical bacteriophage treatment to normalize urine culture compared to intravesical placebo or standard antibiotic treatment in a randomized controlled trial following a pilot phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anbiotica | Active comparator | Drug: Antibiotics |
| Bacteriophages | Active comparator | Biological: PYO Phage |
| Placebo | Placebo comparator | Other: Sterile bacteriology media |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with urinary tract infections who are scheduled for transurethral resection of the prostate with urine culture (taken by mid-stream urine; or from the existing transurethral or suprapubic catheter) ≥104 colony forming units /mL of predefined uropathogens, including Enterococcus spp., Escherichia coli, Proteus mirabilis, Pseudomonas aeruginosa, Staphylococcus spp., and Streptococcus spp. and lower urinary tract symptoms such as urgency, frequency, dysuria, increased number of incontinence episodes
- Written informed consent.
Key exclusion criteria (7 listed)
- Fever >38°C
- CRP >100mg/L
- Acute prostatitis
- Concomitant fungal urinary tract infection
- Current antibiotic treatment or antibiotic treatment within the last 7 days (exceptions: subjects with an active catheter associated urinary tract infection who have received prior antibiotics may be enrolled provided a minimum of 48 hours has elapsed between the last dose of the prior antibiotic and the time of obtaining the baseline urine specimen. Subjects receiving current antibiotic prophylaxis for catheter associated urinary tract infection who present signs and symptoms consistent with an active new catheter associated infection may be enrolled provided all other eligibility criteria are met including obtaining a pre-treatment qualifying baseline urine culture)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PYO PhageIntravescial instillation | Biological | Bacteriophages |
| AntibioticsOral application | Drug | Anbiotica |
| Sterile bacteriology mediaSterile bacteriology media, with identical color as bacteriophage preparation | Other | Placebo |
Primary outcome
Normalisation of urine culture
Time frame: 7 days after treatment
Success of intravesical treatment, defined as normalization of urine culture (no evidence of bacteria, i.e. <104 colony forming units/mL) after 7 days of bacteriophage, placebo, or antibiotic treatment
4 secondary outcomes
Urine culture
Time frame: Baseline and 7 days after treatment
Bladder diary
Time frame: Baseline and 7 days after treatment
Pain diary
Time frame: Baseline and 7 days after treatment
IPSS questionnaire
Time frame: Baseline and 7 days after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Derived from this study: PubMed 32949500Leitner L, Ujmajuridze A, Chanishvili N, Goderdzishvili M, Chkonia I, Rigvava S, Chkhotua A, Changashvili G, McCallin S, Schneider MP, Liechti MD, Mehnert U, Bachmann LM, Sybesma W, Kessler TM. Intravesical bacteriophages for treating urinary tract infections in patients undergoing transurethral resection of the prostate: a randomised, placebo-controlled, double-blind clinical trial. Lancet Infect Dis. 2021 Mar;21(3):427-436. doi: 10.1016/S1473-3099(20)30330-3. Epub 2020 Sep 16.
- Derived from this study: PubMed 28950849Leitner L, Sybesma W, Chanishvili N, Goderdzishvili M, Chkhotua A, Ujmajuridze A, Schneider MP, Sartori A, Mehnert U, Bachmann LM, Kessler TM. Bacteriophages for treating urinary tract infections in patients undergoing transurethral resection of the prostate: a randomized, placebo-controlled, double-blind clinical trial. BMC Urol. 2017 Sep 26;17(1):90. doi: 10.1186/s12894-017-0283-6.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PYO Phage, Antibiotics and Sterile bacteriology media in people with Intravesical Bacteriophage Treatment for Urinary Tract Infections, run by Balgrist University Hospital at 1 site in Georgia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normalisation of urine culture (time frame: 7 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03140085, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.